Study of Tibial Shaft Fractures in Children

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Tibial Shaft Fractures in Children

Treatments: Procedure: Long leg cast in full extension; Procedure: Long leg cast with 45 degrees of flexion

Study type: Interventional

Funder types: Other

Identifiers

NCT01238523

OH-001

Details and patient eligibility

About

Tibial shaft fracture is one of the most common fractures in children and adolescents. It encompasses approximately 15 % of all long-bone fractures and is third behind only fractures of the femur and both bones of the forearm. (2). Although most authorities agree that closed tibial shaft fractures are best treated by immobilization in a long-leg cast, there is no clear consensus as to when to allow weight bearing on the injured extremity. While most recent articles have recommended long-leg casts with the knee bent in flexion of 30-60 degrees to preclude weight-bearing(1,2,3,4), other authors have recommended much less flexion, 0-5 degrees, to encourage early weight bearing.(5).

The purpose of this randomized controlled prospective study is to determine if the position of immobilization of the knee influences the rate of healing, delayed union, and nonunion As well, we will assess if the type of immobilization affects the function of the patient during the period of treatment using the Activities Scale for Kids - Performance (ASK-P) child self-report musculoskeletal outcome measure . A minimum of 36 patients in each group for a total of 72 patients between 4 and 14 years of age (open physis) with closed fractures of the tibia, with or without fracture of the fibula, will be included in the study

Enrollment: 81 patients

Sex: All

Ages: 4 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients between 4 and 14 years of age (open physis)
• Patients seen at the Los Angeles Orthopaedic Medical center within 7 days of the original injury
• All closed tibia and tibia and fibula shaft fractures regardless of fracture pattern

Exclusion criteria

• Fractures with greater than 2 cm of initial shortening
• Open fractures
• Patients that have other orthopaedic medical issues such as hemophilia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

Long leg cast in full extension

Experimental group

Description:

Long leg cast in full extension with instructions to begin immediate weight bearing as tolerated on the injured extremity

Treatment:

Procedure: Long leg cast in full extension

Long leg cast with 45 degrees of flexion

Experimental group

Description:

Long leg cast with 45 degrees of flexion at the knee with instructions not to bear weight on the injured extremity

Treatment:

Procedure: Long leg cast with 45 degrees of flexion